Emtricitabine
As of the edition of 20 October 2026, Emtricitabine is a small molecule: marketed, first approved in 2003 (US); US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Emtriva
- First approved
- 2 July 2003 (US)
- Approvals on record
- 36 in 5 regions
- Holder of the most recent approval
- Gilead Sciences; 10 holders in all
- Registered trials
- 320, 27 stopped early
- Disease areas
- Infections; Urinary and reproductive; Immune system; Digestive system; Mental health; Chemically induced
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Gilead Sciences.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 64 | 38 | 5 | 9 |
| Phase 1 | 40 | 34 | 2 | 3 |
| Phase 2 | 57 | 40 | 6 | 6 |
| Phase 3 | 55 | 46 | 5 | 1 |
| Phase 4 | 104 | 74 | 7 | 8 |
| All trials | 320 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Originator, Applicant, Later holder and Lead sponsor of trials | 2002 to now |
| Japan Tobacco | Applicant | 2005 to now |
| Johnson & Johnson | Applicant, Later holder and Lead sponsor of trials | 2008 to now |